Influence of Co-diagnosis of Chronic Fatigue Syndrome in Patients With Fibromyalgia.

Active, not recruiting

• Conditions: Chronic Fatigue Syndrome; Comorbidities and Coexisting Conditions; Fibromyalgia
• Interventions: Behavioral: Subjective quality of live; Procedure: Blood extraction; Behavioral: Accelerometry; Dietary Supplement: Synbiotic complement

• Registration Number: NCT05323838
• Lead Sponsor: University of Extremadura

Brief Summary

The purpose of this study is to evaluate differences in neuroimmunoendocrine response and quality of live in patients diagnosed with Fibromyalgia, with or without a co-diagnosis of Chronic Fatigue Syndrome.

Detailed Description

The limited literature published in concordant relation affects the chronic fatigue syndrome comorbidity in the daily life of fibromyalgia patients leads us to design this study with the main objective of evaluating differences in the quality of life associated with pain and stress, mainly in relation to levels of physical activity, sedentary lifestyle and sleep in patients diagnosed with fibromyalgia, with or without a parallel co-diagnosis of chronic fatigue syndrome.

Study Timeline

• Study Start: 2021-06-09
• Primary Completion: 2021-06-22
• Study First Submitted: 2022-03-18
• Study First Submitted QC: 2022-04-11
• Study First Posted: 2022-04-12
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-09
• Last Update Posted: 2023-05-11
• Study Completion: 2024-11-16

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 140

Inclusion Criteria

• Fibromyalgia and/or Chronic Fatigue Syndrome diagnosis by rheumatologists or internal medicine professionals.
• Age not less than 40 years old and not more than 65 years old.

Exclusion Criteria

• Suffering from diagnosed "major depression".
• Suffer diagnosed multiple chemical sensitivity.
• Corticosteroid treatment or anti-cytokine therapies.
• Periodically carry out programmed therapeutic physical activity in the two months prior to the accelerometry tests.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Only Fibromyalgia	Blood extraction	Patients diagnosed only with fibromyalgia.
Only Fibromyalgia	Subjective quality of live	Patients diagnosed only with fibromyalgia.
Only Fibromyalgia	Synbiotic complement	Patients diagnosed only with fibromyalgia.
Fibromyalgia and Chronic Fatigue Syndrome	Blood extraction	Patients diagnosed with fibromyalgia and chronic fatigue syndrome.
Control Healthy Women	Subjective quality of live	Aged-matched control group of healthy women.
Control Healthy Women	Blood extraction	Aged-matched control group of healthy women.
Control Healthy Women	Accelerometry	Aged-matched control group of healthy women.
Only Fibromyalgia	Accelerometry	Patients diagnosed only with fibromyalgia.
Fibromyalgia and Chronic Fatigue Syndrome	Subjective quality of live	Patients diagnosed with fibromyalgia and chronic fatigue syndrome.
Fibromyalgia and Chronic Fatigue Syndrome	Accelerometry	Patients diagnosed with fibromyalgia and chronic fatigue syndrome.
Fibromyalgia and Chronic Fatigue Syndrome	Synbiotic complement	Patients diagnosed with fibromyalgia and chronic fatigue syndrome.

Primary Outcome Measures

Name	Time	Method
Differences in perceived anxiety using the State-Trait Anxiety Inventory (STAI)	During the intervention, at day 1.	State-Trait Anxiety Inventory (STAI) is a self-reported, scientifically validated questionnaire that measures perceived anxiety. The STAI has 20 items for assessing trait anxiety and 20 for state anxiety. State anxiety items include: "I am tense; I am worried" and "I feel calm; I feel secure." Trait anxiety items include: "I worry too much over something that really doesn't matter" and "I am content; I am a steady person." All items are rated on a 4-point scale (e.g., from "Almost Never" to "Almost Always"). Higher scores indicate greater anxiety.
Differences in fear of Coronavirus Disease (COVID-19) using the Fear COVID-19 Scale (FCV-19S)	During the intervention, at day 1.	The Fear of COVID-19 Scale (FCV-19S) is used to identify and intervene early, psychologically, in people with high values of fear of COVID-19. This one-dimensional scale is made up of seven items with a 5-point Likert response ranging from 1 (strongly disagree) to 5 (strongly agree) and the total tables can range between 7 and 35 points. The higher the score, the greater the fear of COVID-19 infection.
Differences in perceived stress using The Perceived Stress Scale (PSS)	During the intervention, at day 1.	The Perceived Stress Scale (PSS) is a self-reported, scientifically validated questionnaire that measures perceived stress. This scale is a self- report instrument that evaluates the level of perceived stress during the last month, and consists of 14 items with a 5-point response scale (0 = never, 1 = almost never, 2 = once in a while, 3 = often, 4 = very often). The total score of the PSS is obtained by reversing the scores of items 4, 5, 6, 7, 9, 10, and 13 (in the following manner: 0 = 4, 1 = 3, 2 = 2, 3 = 1, and 4 = 0) and subsequently adding the 14 item scores. A higher score indicates a higher level of perceived stress.
Determination of immuno-neuroendocrine parameters (cytokines, catecholamines, and stress hormones)	Through study completion, an average of 2 year	Cytokines (IL-8, IL-10), catecholamines (such as epinephrine, and norepinephrine) as well as stress hormones (serotonin and cortisol), were analyzed by competitive inhibition enzyme immunoassays (ELISA)
Differences in perceived pain using the Brief Pain Inventory (BPI)	During the intervention, at day 1.	Brief Pain Inventory (BPI) is a self-reported, scientifically validated questionnaire that measures perceived pain. The BPI starts with a screening question, asking about the presence of pain and a body chart is used to indicate painful regions as well as the worst region. These items aren´t evaluated. This is followed by the core BPI items: the rating scales for pain severity and interference. Numerical rating scales from 0 to 10 are used for all items. The anchors for pain severity scales are 0 = 'no pain' and 10 = 'pain as bad as you can imagine', whilst the interference anchors are 0 = 'no interference' and 10 = 'interferes completely'.
Differences in subjective quality of sleep using The Pittsburgh Sleep Quality Index (PSQI)	During the intervention, at day 1.	The Pittsburgh Sleep Quality lndex (PSQI) contains 19 self-rated questions and 5 questions rated by the bed partner or roommate (if one is available). Only self-rated questions are included in the scoring.; The 19 self-rated items are combined to form seven "component" scores, each of which has a range of 0-3 points. In all cases, a score of "0" indicates no difficulty, while a score of "3" indicates severe difficulty. The seven component scores are then added to yield one "global" score, with a range of 0-21 points, "0" indicating no difficulty and "21 " indicating severe difficulties in all areas.
Differences in subjective quality of life using The Healthy Lifestyle and Personal Control Questionnaire (HLPCQ)	During the intervention, at day 1.	The Healthy Lifestyle and Personal Control Questionnaire (HLPCQ) This is a 26-item tool in which the respondent is asked to indicate the frequency of adopting 26 positively stated lifestyle habits using a Likert-type scale (1=Never or rarely, 2=Sometimes, 3=Often, and 4 = Always).
Differences in perceived depression using the Beck's Depression Inventory (BDI)	During the intervention, at day 1.	Beck's Depression Inventory (BDI) is a self-reported, scientifically validated questionnaire that measures perceived depression. Each of the 21 items on the BDI measures the presence and severity of a symptom of depression by requiring a self-rating from 0 to 3. Mild (low) scores are less than 4; moderate (medium) is between 14 and 20, and severe 21 and above. Unless otherwise indicated, the use of "mild," "moderate," and "severe" levels of depression throughout the remainder of this chapter will refer to the aforementioned ranges.
Differences in perceived pain using the Brief Fatigue Inventory (BFI)	During the intervention, at day 1.	The Brief Fatigue Inventory (BFI) has nine items, with the items measured on 0-10 numeric rating scales. Three items ask patients to rate the severity of their fatigue at its "worst," "usual," and"now" during normal waking hours, with 0 being "no fatigue" and 10 being "fatigue as bad as you can imagine." Six items assess the amount that fatigue has interfered with different aspects of the patient's life during the past 24 hours. The interference items include general activity, mood, walking ability, normal work, relations with other people, and enjoyment of life. The interference items are measured on a 0 -10 scale, with 0 beings "does not interfere" and 10 being "completely interferes."
Differences in perceived anxiety related to Coronavirus Disease (COVID-19) using the Coronavirus Anxiety Scale (CAS)	During the intervention, at day 1.	The Coronavirus Anxiety Scale is a brief mental health screener that can be used to identify cases of dysfunctional anxiety related to COVID-19. The items measure physiologically-based symptoms that are aroused with coronavirus-related information and thoughts using a 5-point time anchored scale (0=not at all to 4=nearly every day over the last 2 weeks).
Objective differences in physical activity, sedentary lifestyle and sleep using the accelerometer technique (ActiGraph)	Up to 1 week	An accelerometer is a small device, like a wristwatch, used to measure physical activity level, patterns of activity, sedentary levels, sleep patterns, and the expenditure of calories consumed, basal and total Metabolic Equivalent of Task (METs) used as an assessment of the metabolism of the person wearing it.

Trial Locations

Locations (1)

University of Extremadura; 🇪🇸 Badajoz, Spain